Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT00243204
Status:
TERMINATED
Last Update Posted:
2007-06-08
First Post:
2005-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C477478', 'term': 'PT-100 dipeptide'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'whyStopped': 'FDA Hold May 2007', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2007-06-07', 'studyFirstSubmitDate': '2005-10-19', 'studyFirstSubmitQcDate': '2005-10-19', 'lastUpdatePostDateStruct': {'date': '2007-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-21', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Stage IIIb/IV non-small cell lung cancer', 'NSCLC', 'Lung Cancer'], 'conditions': ['Carcinoma, Non-Small Cell Lung']}, 'descriptionModule': {'briefSummary': 'This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Men or women age 18 years or older\n* Histologically or cytologically confirmed NSCLC\n\n * Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV)\n * Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion\n* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC\n* Measurable disease on computerized tomography (CT) scan\n* ECOG Performance Status of 0 or 1\n* Expected survival ≥12 weeks\n* Provide written informed consent\n\nEXCLUSION CRITERIA:\n\n* More than 2 prior chemotherapy regimens\n* Clinically significant laboratory abnormalities, specifically:\n\n * Total bilirubin ≥ institutional upper limit of normal (ULN)\n * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \\>2.5 x ULN\n * Serum creatinine ≥2.0mg/dL\n * Absolute neutrophil count \\<1500/μL or platelets \\<100,000/μL\n* Untreated or symptomatic brain metastases\n* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix\n* A history of severe hypersensitivity to drugs formulated with polysorbate 80\n* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol\n* Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC.\n* Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.'}, 'identificationModule': {'nctId': 'NCT00243204', 'briefTitle': 'Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Point Therapeutics'}, 'orgStudyIdInfo': {'id': 'PTH-304'}}, 'armsInterventionsModule': {'interventions': [{'name': 'talabostat mesylate', 'type': 'DRUG'}, {'name': 'docetaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Marshall Schreeder, MD', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'James P. Daugherty, MD', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Cancer Research', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hematology Oncology Associates', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Veena Charu, MD', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Lalita Pandit, MD, Inc', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Robert A. Moss, MD, FACP, Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Warren Paroly, MD', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Swarna S. Chanduri, MD', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '92064-2527', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Southwest Cancer Care Medical Group', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Mile High Oncology', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Medical Specialists of Fairfield', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '34613', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'facility': 'Pasco Hernando Oncology Associates PA', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Lucio Gordan, MD', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Citrus Hematology and Oncology Center', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Nature Coast Clinical Research, LLC', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Jorge G. Otoya, MD', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '34461', 'city': 'Lecanto', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer and Blood Disease Center', 'geoPoint': {'lat': 28.85165, 'lon': -82.4876}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Pasco Hernando Oncology Associates, PA', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Oncology Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Center of Florida', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hematology Oncology Associates of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Joliet Oncology Hematology Associates', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hematology Oncology Consultants', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46617', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northern Indiana Oncology Associates', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Cancer Centers, Southwest', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '41701', 'city': 'Hazard', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Cancer Clinic', 'geoPoint': {'lat': 37.24954, 'lon': -83.19323}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Medical Oncology, LLC', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Oncology Hematology, PA', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Oncology Hematology Associates (Tate Center)', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'zip': '48183', 'city': 'Brownstown', 'state': 'Michigan', 'country': 'United States', 'facility': 'Josephine Ford Cancer Center -- Downriver'}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michael McKenzie, DO', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '48126', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Medical Center -- Fairlane', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48060', 'city': 'Port Huron', 'state': 'Michigan', 'country': 'United States', 'facility': 'Youssef Hanna, MD', 'geoPoint': {'lat': 42.97086, 'lon': -82.42491}}, {'zip': '48307', 'city': 'Rochester Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cancer and Transplant Consultants, PLC', 'geoPoint': {'lat': 42.65837, 'lon': -83.14993}}, {'zip': '48307', 'city': 'Rochester Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cancer Care Associates', 'geoPoint': {'lat': 42.65837, 'lon': -83.14993}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cancer Care Associates, PC', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hematology Oncology Consultants', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Jeffrey H. Margolis, MD', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oncology Care Associates, PLLC', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '48195', 'city': 'Southgate', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Hematology and Oncology Institute', 'geoPoint': {'lat': 42.21393, 'lon': -83.19381}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Mitchell Folbe, MD, PC', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Medical Center', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '64507', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Joseph Oncology, Inc.', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Arch Medical Services, Inc.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Billings Clinic', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08003', 'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Center for Cancer and Hematologic Disease', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'New York Oncology Hematology, PC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11545', 'city': 'Glen Head', 'state': 'New York', 'country': 'United States', 'facility': 'George A. Zervos, MD', 'geoPoint': {'lat': 40.83538, 'lon': -73.62374}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Northwestern Carolina Oncology Hematology', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oncology/Hematology Care, Inc.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44622', 'city': 'Dover', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.52062, 'lon': -81.47401}}, {'zip': '45409', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton Hematology and Oncology', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '44256', 'city': 'Medina', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mukesh C. Bhatt, MD', 'geoPoint': {'lat': 41.13839, 'lon': -81.86375}}, {'zip': '44691', 'city': 'Wooster', 'state': 'Ohio', 'country': 'United States', 'facility': 'Trilogy Cancer Center', 'geoPoint': {'lat': 40.80517, 'lon': -81.93646}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Cancer Specialists, Northrup', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17325', 'city': 'Gettysburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Shatish A. Shah, MD', 'geoPoint': {'lat': 39.83093, 'lon': -77.2311}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Medical Oncology Associates of Wyoming Valley, PC', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rittenhouse Hematology Oncology Associates', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19380', 'city': 'West Chester', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Chester County Hematology / Oncology Services', 'geoPoint': {'lat': 39.96097, 'lon': -75.60804}}, {'zip': '29801', 'city': 'Aiken', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Care Institute of Carolina', 'geoPoint': {'lat': 33.56042, 'lon': -81.71955}}, {'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Charleston Hematology Oncology, 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